Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases

Sponsor
Fudan University
Study ID
NCT07466927
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • HER2-negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1811 — DRUG
    A HER2-directed ADC, via intravenous (into the vein) infusion per protocol.
  • SKB264 — DRUG
    A TROP2-directed ADC, via intravenous (into the vein) infusion per protocol.
  • Pembrolizumab — DRUG
    PD-1 antibody, via intravenous (into the vein) infusion per protocol.
  • SHR-1316 — DRUG
    PD-L1 antibody, via intravenous (into the vein) infusion per protocol.

Study Details

This is a prospective, open-label, phase II platform trial. The purpose of this study is to test the safety and effectiveness of multi-mode thermal therapy combined with immunotherapy in patients with HER2-negative breast cancer with liver metastases who had previously received systemic therapy

Key Dates

First listed
Mar 12, 2026
Start date
Mar 15, 2026
Status verified
Mar 2026
Primary completion
Jan 15, 2028
Completion
Jan 15, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HER2(0)
    Pembrolizumab + SKB264（Trop2 ADC）
  • Experimental: HER2-low
    SHR1316(PD-L1 antibody) + SHR-A1811(HER2 ADC)

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: The observation period related to this endpoint is up to 12 months. ]

Central Contacts

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